Newsletter | August 28, 2024

08.28.24 -- Clinical Trials In China Reboot BIOSECURE Act

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Webinar: Advances in Oral GLP-1 Analogs for Obesity: Market Insights, Challenges, and Delivery Strategies

Join us on September 12, 2024, at 11:00am EDT as we explore the impact of oral GLP-1 analogs on obesity treatment. We’ll cover their role in improving patient adherence and market expansion while addressing challenges like stability and bioavailability. Key topics include the significance of GLP-1 analogs, market growth, and innovative delivery strategies. Click here to learn more.

FEATURED EDITORIAL

Clinical Trials In China Reboot BIOSECURE Act

Clinical trials are not my beat, but the BIOSECURE Act targeting CDMOs sure is. Now the congressional committee involved with putting that legislation together has found something of perhaps more substance, and better substantiated, to add to the impetus of the Act: clinical trials in China.

The High Life And Times Of a Qualified Person (QP) In Europe

You must be appropriately qualified, trained, accepted by the relevant competent authority in the European Union, and named on a site’s authorization. According to Nolliag Buckley, a Qualified Person (QP) also needs more. “Honest to God, you must be creative. That sort of individual skill is helpful. I'm a troubleshooter. That's what I love.”

VR/XR In Drug Manufacturing: No Longer Sci-Fi

Virtual reality (VR) immerses users in a completely simulated environment, while extended reality (XR) is an umbrella term encompassing VR, augmented reality, and mixed reality. These capabilities open up a world of possibilities for drug manufacturing.

INDUSTRY INSIGHTS

Demonstrating Control Over The Manufacturing Process: QbD Studies

Understand the importance of fate and purge studies, which measure the ability of the process to remove impurities and provide evidence of their removal.

Dry Powder Inhalable Vaccines For Shelf Stability And Global Access

Complex storage requirements can result in limited access to vaccines. Explore the formulation of vaccines with dry powder respiratory delivery in mind and manufacturing considerations for dry powder inhaled vaccines.

Overcoming Challenges Of Manufacturing For Clinical Trials

Learn how CROs and CDMOs work in tandem to address operational and regulatory challenges for sponsor companies, and how this can determine study success or failure.

Ensuring The Efficacy Of Probiotic Products

Without proper handling and packaging, probiotics can be compromised at any point in the packaging, storage, and transportation process, impacting shelf life and efficacy.

Formulation Technologies For Developing Dry Powders For Inhalation

Examine challenges and considerations for spray-dried formulations for inhalation, along with a review of technologies and products utilizing particle engineering approaches.

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Webinar: New Data: NanoImprove Bioavailability, Drug Loads and Pill Burdens of your Solid Dispersions

Join us on September 10th to discover how Nanoforming can revolutionize drug formulations. Learn how this cutting-edge technology improves bioavailability, reduces pill size and burden, and enhances patient convenience compared to traditional amorphous solid dispersions. Don't miss the opportunity to explore new data showing how a single Nanoformed tablet can outperform multiple ASD tablets. Click here to learn more.

SOLUTIONS

Drug Substance Or API Manufacturing

Our network currently spans across 9 manufacturing sites in 5 countries and can support discovery, preclinical, clinical and commercial programs for NCEs. Review our API capabilities below and contact us to simplify your outsourcing solutions.

A Technology-Driven CDMO Delivering Integrated End-To-End Services

Explore this interactive PDF with information about technologies & end-to-end integrated CDMO services provided by Adare Pharma Solutions.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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